Archive for April 23rd, 2009

I have been talking with Frank Blanchard, Director of Public Affairs for SAIC-Frederick for a while now. We’re trying to do a better job (well at least I am, frank’s already doing a fine job) of getting out the word on what kind of research is being done by SAIC contractors on the Post, primarily with the NCI labs. He’s forwarded a number of interesting articles/Press releases for your reading pleasure.

FREDERICK, Md., March 30, 2009 – Two new nanotechnology concepts will undergo preclinical characterization as part of the National Cancer Institute (NCI) Advanced Technology Partnerships Initiative to accelerate the development of new treatments for cancer patients.

NCI has entered into separate agreements with Azaya Therapeutics Inc. and Lankenau Institute for Medical Research and its collaborating institute, Massachusetts Institute of Technology, to perform preclinical characterization of the companies’ proprietary nanotechnologies as a prelude to early-phase human clinical trials.

Under the Azaya agreement, the NCI’s Nanotechnology Characterization Laboratory (NCL)—operated by SAIC-Frederick, Inc. as part of the NCI Alliance for Nanotechnology in Cancer—will focus on characterization of Azaya’s lead cancer therapy (ATI-1123) for its adsorption, distribution and toxicity properties using standardized physico-chemical, in-vitro, and in-vivo assays.

The studies will provide a better understanding of the physical and biological properties of ATI-1123 and will support Azaya’s Investigational New Drug (IND) filings with the U.S. Food and Drug Administration.

Azaya’s product is an advanced liposomal formulation of the widely prescribed Taxotere® (docetaxel), a drug for breast, gastric, head and heck, ovarian, prostate, and non-small cell lung cancers.

Under a separate agreement, the NCL will perform preclinical studies on Lankenau’s novel therapeutic nanoparticles for treating solid tumors.

The initial study will focus on adsorption, distribution, and toxicity properties of Lankenau’s polymeric nanoparticle delivery system, which is designed to deliver toxin to tumors without harming normal tissue. Early stage laboratory studies targeted models of prostate, ovarian, pancreatic, and cervical cancers.

Both agreements fall under the ATPI, which seeks to accelerate the development and delivery of new treatments to cancer patients through strategic partnerships with industry, academia, and the nonprofit sector.

An inexpensive and widely used additive to food and cosmetics has been shown to prevent transmission of a primate version of the AIDS virus.

The research, published online in the March 4 issue of the journal Nature, represents a novel strategy in the search for a safe, affordable, and effective means to prevent the spread of AIDS, especially via sexual transmission to women.

The strategy exploits a recent finding about sexual transmission of AIDS viruses. Using a monkey model of sexual transmission of AIDS virus, the scientists showed that vaginal exposure to the virus, even in excessive amounts, initially only infects a relatively small number of cells. Without additional target cells, the infection would fail to progress, remain localized, and not cause AIDS.

The immune system, however, responds to the virus by recruiting immune cells (T cells) to the site of infection. This provides the virus with new target cells and the means to spread and establish a systemic infection that can lead to AIDS.

In the current research, investigators at the University of Minnesota, SAIC-Frederick, and collaborating institutions wondered if dampening the initial host response might deprive the virus of new target cells and thereby prevent the virus from establishing itself throughout the body.

In testing this novel idea, they focused on the critical window of opportunity at the earliest stages of infection, when only a limited number of cells are infected, before the virus has spread, a time when the virus is most vulnerable. To try to block recruitment of new target cells by the virus, they chose a safe, widely used compound-glycerol monolaurate (GML).

GML is a naturally occurring compound used in food and cosmetics to protect consumers from microbes and associated inflammatory reactions, including toxic shock syndrome. GML has antibacterial properties, but also inhibits signaling molecules that stimulate the immune system, which can cause inflammation.

The scientists used a primate version of HIV known as simian immunodeficiency virus (SIV). Applied vaginally, GML prevented infection even after repeated exposure to high doses of the monkey virus.

“This result represents a highly encouraging new lead in the search for an effective microbicide to prevent HIV-1 transmission that meets the criteria of safety, affordability, and efficacy,” the group reported.

GML is a novel approach in that it lacks the direct antiviral activity of most compounds that have been used so far to try to block sexual transmission of HIV. But the initial success of this approach might be enhanced further by using GML or a similar compound in combination with antiviral agents that directly attack the virus.

While the results are promising, additional research involving larger groups of animals over longer periods of time will be necessary before human clinical trials can be considered.

The research is in line with an intensive new focus in the battle against AIDS. With limited progress toward a vaccine, and the rampant spread of the disease, scientists are looking with renewed interest at prevention strategies that focus on sexual transmission, which is leading the spread of the disease worldwide.

Globally, there were 2.7 million new cases of HIV and 2 million HIV-related deaths in 2007 (www.unaids.org). In sub-Saharan Africa, which accounts for nearly one-third of new HIV infections and AIDS death globally (www.unaids.org), young women are more than three times as likely to be infected as young men. This underscores the importance of developing prevention strategies that young women can use to protect themselves from HIV infection. Approaches based on the new research may help meet this need.

In the current work, the research group first tested the safety of daily vaginal applications of GML for six months in a group of rhesus macaques and found no side effects. Nine monkeys received a warming gel with GML added and three monkeys received the warming gel alone as a control.

The next step was to test the effectiveness of GML against the primate virus. Two animals with a warming gel plus GML and two with the warming gel alone were exposed vaginally to high doses of SIV, and then re-exposed to the virus. They continued to receive daily doses of the active and placebo gels. As a result, both of the GML-treated animals were completely protected from acute systemic infection. One of the placebo-receiving monkeys, however, became infected with SIV.

The researchers followed up by repeatedly exposing three additional GML-treated monkeys and three control animals to the virus over a period of weeks. Again, GML-treated animals were spared from acute infection, but all three in the control group became infected.

The lead investigator is Ashley Haase of the University of Minnesota. Collaborators include Jeff Lifson, M.D., head of the AIDS and Cancer Virus Program Directorate, and Jacob Estes, Ph.D., ACVP;and researchers from the Wisconsin Primate Research Center.Ceres Nanosciences and SAIC-Frederick Collaborate
On Cancer Steroid Hormone Studies

And a recent Press Release last week:

FREDERICK, Md., April 22, 2009 – Ceres Nanosciences, LLLP, and National Cancer Institute contractor SAIC-Frederick, Inc., a wholly owned subsidiary of Science Applications International Corporation (NYSE: SAI), have signed a collaboration agreement to assess Ceres’ nanotechnology-based system that can isolate scant amounts of substances in body fluids, with an eye toward developing tools for diagnosing cancer at the earliest possible stage when treatments are most effective.

Under the agreement, SAIC-Frederick laboratories will begin by assessing Ceres’ NanotrapTM technology in an effort to identify from body fluids extremely low concentrations of steroid hormones.

The agreement was formed under the National Cancer Institute’s Advanced Technology Partnerships Initiative (ATPI), which aims to further NCI’s mission by rapidly translating the results of basic research into new tests and treatments for cancer patients. SAIC-Frederick, as prime contractor at the National Cancer Institute at Frederick, is facilitating ATPI partnerships for the government.

“The role that steroid hormones play in cancer continues to be a research area of great interest,” said Timothy Veenstra, Ph.D., Head of Laboratory Proteomics Analytical Technologies at SAIC-F. “Our intent in developing the Ceres NanotrapTM is to increase the speed and accuracy with which samples can be processed and analyzed. This will lead to a better understanding of the role that steroid hormones play in cancer.”

“This collaboration with SAIC-F is an ideal match for Ceres,” said Ross Dunlap, Chief Operating Officer of Ceres Nanosciences. “It is aligned with our mission to develop an integral technology for more efficient and effective sample processing and disease diagnosis. We are very excited to partner with Dr. Veenstra’s team in support of the cancer research programs at SAIC-F.”

Ceres’ NanotrapTM technology is a nanoparticle platform developed to better capture low-abundance biomarkers and protect them from degradation. The NanotrapTM collection process, coupled with existing clinical diagnostic platforms, has the potential of significantly improving efficiency, reliability, sensitivity and accuracy of a wide range of critical diagnostic processes. This may improve diagnosis of diseases, including cancer, at their earliest stages.

About Ceres Nanosciences, LLLP

Ceres Nanosciences, LLLP is a privately held company focused on the development of diagnostic products using its unique and proprietary NanotrapTM capture particle technology. Ceres’ business goals are to develop a number of commercial applications of the NanotrapTM for high-demand diagnostics and other needs in the life science industry.

About SAIC-Frederick

SAIC-Frederick, Inc., a wholly owned subsidiary of Science Applications International Corporation (SAIC), a Fortune 500® company, is the operations and technical support contractor for the National Cancer Institute’s research and development center in Frederick, Md. This is a national laboratory dedicated to rapidly translating basic research into new technologies for diagnosing, treating, and preventing cancer and AIDS. SAIC-Frederick maintains a full suite of advanced technologies in areas such as nanotechnology, genomics and imaging; operates the federal government’s only drug and vaccine manufacturing facilities; operates the high-performance Advanced Biomedical Computing Center; and supports more than 300 clinical trials for patients in the United States and around the world.

Information about the NCI’s Advanced Technology Partnerships Initiative can be found at ATPIhome.com